This trial is active, not recruiting.

Conditions diphtheria, tetanus, whooping cough, hepatitis b, poliomyelitis, invasive hib infections
Treatment hexaxim™: dtap-ipv-hep b-prp~t combined vaccine
Phase phase 3
Sponsor Sanofi Pasteur, a Sanofi Company
Start date February 2014
End date December 2014
Trial size 177 participants
Trial identifier NCT01948193, A3L33, CTRI/2013/09/003997, U1111-1127-6936


The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India.

Primary Objective:

- To evaluate the immunogenicity of the study vaccine in terms of seroprotection [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one month after the third dose.

Secondary Objectives:

- To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose.

- To describe the safety after each and any doses of the study vaccine.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Participants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T combined vaccine (investigational vaccine) at 6, 10 and 14 weeks of age.
hexaxim™: dtap-ipv-hep b-prp~t combined vaccine Hexaxim™
0.5 mL, Intramuscular

Primary Outcomes

Summary of levels of antibodies to the vaccine antigens following 3 doses of DTaP-IPV-Hep B-PRP~T, Sanofi Pasteur's hexavalent vaccine
time frame: Day 30 (post 3rd vaccination)

Secondary Outcomes

Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events after booster administration of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine.
time frame: Day 0 to up to 3 months post-vaccination

Eligibility Criteria

Male or female participants from 6 weeks up to 8 weeks old.

Inclusion Criteria: - Aged between 42-56 days (6 to 8 weeks) on the day of inclusion - Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg - Informed consent form signed by the parent(s) or any other legally acceptable representative - Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures - Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from maternal blood sample performed during last trimester of pregnancy available) - Have received one documented dose of Hep B vaccine and oral poliovirus vaccine (OPV) from birth as per national recommendations. Exclusion Criteria: - Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure - Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except Bacillus Calmette-Guerin [BCG] vaccine) or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination - Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect the birth dose of OPV as per national recommendations) and hepatitis B (except the birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or another vaccine - Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) - History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically) - Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances - Known thrombocytopenia, as reported by the parent/legally acceptable representative - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination - In an emergency setting, or hospitalized involuntarily - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥38°C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided) - Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study - History of seizures.

Additional Information

Official title Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10 and 14 Weeks of Age in Infants From India Who Previously Received a Dose of Hepatitis B Vaccine at Birth
Description All participants will receive a total 4 doses of Hep B, i.e. one dose of Hep B monovalent vaccine given at birth followed by 3 doses of Sanofi Pasteur's hexavalent vaccine given at 6, 10 and 14 weeks of age in the context of the study. Participants and parents will attend four clinic visits; the expected participation in the study is approximately 3 months.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Sanofi.